Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder - Tabular View

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Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

This study has been completed.

Study NCT00000446. Last updated on June 23, 2005. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Official Title ^†	Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Brief Summary	This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial. All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism Post-Traumatic Stress Disorder
Intervention ^†	Drug: sertraline (Zoloft)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date	December 2000
Eligibility Criteria ^†	Inclusion Criteria: Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder. Laboratory tests for blood and urinalysis must be within normal limits. Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions. Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal. Exclusion Criteria: Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days. Currently suicidal. Medical reasons not to receive drug therapy. Allergy or hypersensitivity to selective serotonin inhibitor antidepressants. Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease. Liver function test greater than 2 times the normal level Require ongoing therapy with another psychoactive drug during the study period. Females who are pregnant or lactating.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000446
Organization ID	NIAAABRA10761
Secondary IDs ^††
Study Sponsor ^†	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	April 2004
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.